VSP System
510(k) K210347
VSP System is a medical device (FDA Class II; FDA product code DZJ, Driver, Wire, And Bone Drill, Manual) made by 3D Systems, cleared under FDA 510(k) K210347 on 26 Apr 2021, active as of 22 Oct 2026.
Active
510(k)
Valid until
No expiry
FDA recalls
None found
Documents
Trust
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK210347 | Date26 Apr 2021 | StatusActive |
Official records
- FDA 510(k) database K210347
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- DZJ
- Device class
- Class II
- Regulation
- 21 CFR Part 872.4120
- Advisory committee
- Dental
- FDA decision
- SESE Substantially Equivalent
Devices cleared under K210347
Devices that FDA's GUDID lists as cleared or approved under this submission number. One submission usually covers a whole product family, so the sizes and models are listed here once.
| UDI-DI | Size and differences | |||
|---|---|---|---|---|
| VSP System | Reconstructed Maxilla/Mandible 1-Piece Model | 00816847021098 | — | On the market |
| VSP System | Reconstructed Maxilla/Mandible 2-Piece Model | 00816847021104 | — | On the market |
| VSP System | Repositioned Maxilla/Mandible 1-Piece Model | 00816847021159 | — | On the market |
| VSP System | Repositioned Maxilla/Mandible 2-Piece Model | 00816847021166 | — | On the market |
| VSP System Mandible Model | Mandible Model | 00816847021012 | — | On the market |
| VSP System Maxilla Model | Maxilla Model | 00816847021005 | — | On the market |
| VSP System Maxilla/Mandible 1-Piece Model | Maxilla/Mandible 1-Piece Model | 00816847021036 | — | On the market |
| VSP System Maxilla/Mandible 2-Piece Model | Maxilla/Mandible 2-Piece Model | 00816847021043 | — | On the market |
| VSP System Perfected Mandible Model | Perfected Mandible Model | 00816847021203 | — | On the market |
| VSP System Perfected Maxilla Model | Perfected Maxilla Model | 00816847021197 | — | On the market |
| VSP System Perfected Maxilla/Mandible 1-Piece Model | Perfected Maxilla/Mandible 1-Piece Model | 00816847021227 | — | On the market |
| VSP System Perfected Maxilla/Mandible 2-Piece Model | Perfected Maxilla/Mandible 2-Piece Model | 00816847021234 | — | On the market |
| VSP System Reconstructed Mandible Model | Reconstructed Mandible Model | 00816847021074 | — | On the market |
| VSP System Reconstructed Maxilla Model | Reconstructed Maxilla Model | 00816847021067 | — | On the market |
| VSP System Repositioned Mandible Model | Repositioned Mandible Model | 00816847021135 | — | On the market |
| VSP System Repositioned Maxilla Model | Repositioned Maxilla Model | 00816847021128 | — | On the market |
| VSP System Resected Mandible Model | Resected Mandible Model | 00816847021258 | — | On the market |
| VSP System Resected Maxilla Model | Resected Maxilla Model | 00816847021241 | — | On the market |
| VSP System, VSP Cranial Bone Graft Template | Bone Graft Template | 00816847021272 | — | On the market |
| VSP System, VSP Cranial Full Skull Model | Full Skull Model | 00816847021029 | — | On the market |
| VSP System, VSP Cranial Graft Pre-Contouring Template | Graft Pre-Contouring Template | 00816847021265 | — | On the market |
| VSP System, VSP Cranial Implant Template | Implant Template | 00816847021289 | — | On the market |
| VSP System, VSP Cranial Mirrored Anatomical Model | Mirrored Anatomical Model | 00816847021173 | — | On the market |
| VSP System, VSP Cranial Original Anatomical Model | Original Anatomical Model | 00816847020992 | — | On the market |
| VSP System, VSP Cranial Perfected Anatomical Model | Perfected Anatomical Model | 00816847021180 | — | On the market |
| VSP System, VSP Cranial Perfected Full Skull Model | Perfected Full Skull Model | 00816847021210 | — | On the market |
| VSP System, VSP Cranial Reconstructed Anatomical Model | Reconstructed Anatomical Model | 00816847021050 | — | On the market |
| VSP System, VSP Cranial Reconstructed Full Skull Model | Reconstructed Full Skull Model | 00816847021081 | — | On the market |
| VSP System, VSP Cranial Repositioned Anatomical Model | Repositioned Anatomical Model | 00816847021111 | — | On the market |
| VSP System, VSP Cranial Repositioned Full Skull Model | Repositioned Full Skull Model | 00816847021142 | — | On the market |
| VSP System, VSP Cranial Resected Anatomical Model | Resected Anatomical Model | 00816847021463 | — | On the market |
| VSP System, VSP Cranial Resected Full Skull Model | Resected Full Skull Model | 00816847021456 | — | On the market |
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